Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

Preterm Infants Clinical Trial

Official title:

Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03841994
• Other study ID #: 1801-128-917
• Status: Recruiting
• Start date: December 4, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Seung Han Shin, M.D.
• Phone: +82220727230
• Email: revival421[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Description:

The purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants

• born less than 28+0 weeks gestation

Exclusion Criteria:

• Major congenital anomalies

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (16)

Ardissone AN, de la Cruz DM, Davis-Richardson AG, Rechcigl KT, Li N, Drew JC, Murgas-Torrazza R, Sharma R, Hudak ML, Triplett EW, Neu J. Meconium microbiome analysis identifies bacteria correlated with premature birth. PLoS One. 2014 Mar 10;9(3):e90784. d — View Citation

Cao B, Stout MJ, Lee I, Mysorekar IU. Placental Microbiome and Its Role in Preterm Birth. Neoreviews. 2014 Dec 1;15(12):e537-e545. — View Citation

Choi Y, Kwon Y, Kim DK, Jeon J, Jang SC, Wang T, Ban M, Kim MH, Jeon SG, Kim MS, Choi CS, Jee YK, Gho YS, Ryu SH, Kim YK. Gut microbe-derived extracellular vesicles induce insulin resistance, thereby impairing glucose metabolism in skeletal muscle. Sci Rep. 2015 Oct 29;5:15878. doi: 10.1038/srep15878. — View Citation

Cong X, Henderson WA, Graf J, McGrath JM. Early Life Experience and Gut Microbiome: The Brain-Gut-Microbiota Signaling System. Adv Neonatal Care. 2015 Oct;15(5):314-23; quiz E1-2. doi: 10.1097/ANC.0000000000000191. Review. — View Citation

Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12. Review. — View Citation

DiBartolomeo ME, Claud EC. The Developing Microbiome of the Preterm Infant. Clin Ther. 2016 Apr;38(4):733-9. doi: 10.1016/j.clinthera.2016.02.003. Epub 2016 Mar 2. Review. — View Citation

Kim MH, Rho M, Choi JP, Choi HI, Park HK, Song WJ, Min TK, Cho SH, Cho YJ, Kim YK, Yang S, Pyun BY. A Metagenomic Analysis Provides a Culture-Independent Pathogen Detection for Atopic Dermatitis. Allergy Asthma Immunol Res. 2017 Sep;9(5):453-461. doi: 10.4168/aair.2017.9.5.453. — View Citation

Macfabe DF. Short-chain fatty acid fermentation products of the gut microbiome: implications in autism spectrum disorders. Microb Ecol Health Dis. 2012 Aug 24;23. doi: 10.3402/mehd.v23i0.19260. eCollection 2012. — View Citation

Mshvildadze M, Neu J. The infant intestinal microbiome: friend or foe? Early Hum Dev. 2010 Jul;86 Suppl 1:67-71. doi: 10.1016/j.earlhumdev.2010.01.018. Epub 2010 Feb 8. Review. Erratum in: Early Hum Dev. 2014 Mar;90(3):163-4. — View Citation

Murgas Torrazza R, Neu J. The developing intestinal microbiome and its relationship to health and disease in the neonate. J Perinatol. 2011 Apr;31 Suppl 1:S29-34. doi: 10.1038/jp.2010.172. Review. — View Citation

Rea K, Dinan TG, Cryan JF. The microbiome: A key regulator of stress and neuroinflammation. Neurobiol Stress. 2016 Mar 4;4:23-33. eCollection 2016 Oct. Review. — View Citation

Sanz Y. Gut microbiota and probiotics in maternal and infant health. Am J Clin Nutr. 2011 Dec;94(6 Suppl):2000S-2005S. doi: 10.3945/ajcn.110.001172. Epub 2011 May 4. Review. — View Citation

Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8. — View Citation

Sung J, Kim N, Kim J, Jo HJ, Park JH, Nam RH, Seok YJ, Kim YR, Lee DH, Jung HC. Comparison of Gastric Microbiota Between Gastric Juice and Mucosa by Next Generation Sequencing Method. J Cancer Prev. 2016 Mar;21(1):60-5. doi: 10.15430/JCP.2016.21.1.60. Epub 2016 Mar 30. — View Citation

Wang X, Buhimschi CS, Temoin S, Bhandari V, Han YW, Buhimschi IA. Comparative microbial analysis of paired amniotic fluid and cord blood from pregnancies complicated by preterm birth and early-onset neonatal sepsis. PLoS One. 2013;8(2):e56131. doi: 10.1371/journal.pone.0056131. Epub 2013 Feb 20. — View Citation

Yoo JY, Rho M, You YA, Kwon EJ, Kim MH, Kym S, Jee YK, Kim YK, Kim YJ. 16S rRNA gene-based metagenomic analysis reveals differences in bacteria-derived extracellular vesicles in the urine of pregnant and non-pregnant women. Exp Mol Med. 2016 Feb 5;48:e208. doi: 10.1038/emm.2015.110. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice	within 24 hours after birth
Primary	The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice	2 weeks after birth
Primary	The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice	3~5 weeks after birth
Primary	The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice	at 37~40 weeks of postmenstrual age
Secondary	Brain MRI	white matter injury	at 37~40 weeks of postmenstrual age
Secondary	Bayley scales of infant and toddler development, third edition	For neurodevelopmental screening, Bayley scales of infant and toddler development, third edition yields composite scores for each cognitive, language, motor.; It is considered normal when >85. Developmental delay is diagnosed when the mean result is below 85.; Neurodevelopmental screening is considered normal when a child achieves these all.	at 18~24 months of corrected age
Secondary	Incidence of major morbidity	Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity	at 36~40 weeks of postmenstrual age
Secondary	Comparison of inflammation markers	Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc.	with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
Secondary	Comparison of short chain fatty acid at 4 period	Comparison of short chain fatty acid in stool and blood at 4 period	with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age